Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86
Recall Number: D-1445-2020
Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Classification: Class III
Status: Terminated
Report Date: 20200805
Initiation Date: 20200706
Termination Date: 20230608
Reason for Recall
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Product Description
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86